A Prospective, Comparative, Randomized, Multi-Center, Double-Blinded, Placebo-Controlled, Phase 2a Study of the Safety and Efficacy of CMX-2043 for Periprocedural Injury Protection in Subjects Undergoing Coronary Angiography at Risk of Radio-contrast Induced Nephropathy (CARIN)

Carin [NCT02103959]

Description: The objective of this study is to evaluate CMX-2043 for prevention of renal and cardiac injury associated with coronary angiography in patients with acute coronary syndrome (ACS), but excluding ST-elevation myocardial infarction (STEMI) patients. This study will specifically examine the ability of CMX-2043 to prevent acute renalinjury following coronary angiography. The study will also examine the ability of CMX 2043 for prevention of periprocedural cardiac injury. Information will be obtained relating to the ability of CMX 2043 for prevention of major adverse cardiac and renal events following the procedure. Additional information will be obtained in this study to evaluate safety of the drug. Dose and regimen information will also be obtained for future clinical studies of CMX-2043.

Drug: CXM-2043

Primary Investigator: Kereiakes

Drug/Device Information
To access the efficacy of CMX-2043 for the prevention of renal/cardiac injury with coronary angiography in patients with ACS or non-ACS patients undergoing a high risk elective coronary angiography
CMX-2043(small molecule adduct of lipoic acid) that acts via PI3 kinase pathway to increase phosphorylation of Akt thus activating and potentiating the cells survival response mechanism
Randomized 1:1:1:1 (CMX-2043 2.4 mg/kg, 3.6 mg/kg and 2.4 mg/kg given 2X, placebo)
Ischemix LLC
Major Inclusion and Exclusion
Age ≥ 18 undergoing coronary angiography with a high probability of going on to PCI
Must meet one of the following angiography criteria (A-E):
A. Acute coronary syndrome (excluding STEMI)
B. Undergoing a planned complex PCI (more than 75 mL of contrast dye will likely be used)
C. Undergoing an urgent coronary angiography (scheduled within 24 hours) following a failed stress test
D. Two or more abnormal ischemic regions identified by stress test
E. An eGFR between 15.0 – 45.0 mL/min and diabetes mellitus who are undergoing elective coronary angiography
eGFR between 15.0 - 45.0
eGFR between 45.1 - 60.0 with an additional risk (>75, DM, EF < 40, hypotension, CHF or hemoglobin < 10)
No cardiac arrest associated or life threatening arrhythmia with the current admission
No > 125 kg